MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) UNKNOWN AQM DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number MAE UNK AQM DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/01/2007

Event Type  Injury  

Event Description

Dua, m.M., worhunsky, d.J., hwa, k., poultsides, g.A., norton, j.A., <(>&<)> visser, b.C.(2014).Extracorporeal pringle for laparoscopic liver resection.Surgical endoscopy, 29(6), 1348¿1355.Https://doi.Org/10.1007/s00464-014-3801-6 abstract background a primary concern during laparoscopic liver resection (laplr) is hemorrhage during parenchymal transection.Intermittent pedicle clamping is an effective method to minimize blood loss during open liver surgery; however, inflow occlusion techniques are challenging to reproduce during laparoscopy.The purpose of this study is to describe the safety and efficacy of a facile method for pringle maneuver during laplr.Methods 154 patients who underwent laplr from 2007 to 2013 were retrospectively reviewed.For pringle, the hepatoduodenal ligament is encircled with an umbilical tape which is externalized through a flexible rumel tourniquet running alongside a port used for the operation.The internal end of the catheter is close to the pedicle and the external end is extracorporeal, allowing for easy external occlusion.Patients who underwent pringle maneuver (pm, n = 88) were compared to patients who had ¿¿no occlusion¿¿ (no, n = 66) with respect to patient characteristics, operative outcomes, changes in postoperative liver functions, and complications.Results annual placement of the tourniquet and vascular occlusion increased from 35.7 to 82.8 % (p = 0.004) and 21.4 to 62.1 % (p = 0.02), respectively.Median occlusion time was 24 min (iqr 15¿34.3, min 5, max 70).Peak transaminase levels were comparablebetween groups (ast 298 ± 32 vs 405 ± 47 u/l, p = 0.15; alt 272 ± 27 vs 372 ± 34 u/l, p = 0.14, no and pm, respectively).Postoperative transaminase and bilirubin levels for both groups were not significantly different with similar recovery to baseline.Subgroup analysis of cirrhotic patients who underwent pringle demonstrated similar transaminase profiles compared to non-cirrhotic patients.There were two conversions (1.3 %) and postoperative 30-day mortality was 0.65 %.Conclusion extracorporeal tourniquet placement in lap lr is a quick and safe method of gaining control for inflow occlusion.Routine adoption of laparoscopic pringle maneuver facilitates low conversion rates without liver injury.1 case of liver failure and multi organ failure and death postoperatively on day 21.2 procedures required conversion to open surgery.One case was for hemorrhage from the right hepatic vein during paranchymal transection of a right posterior sectorectomy.The other was for a rupture of a 3/4b hepatoma which occurred at the beginning of the case from pulling the omentum of the tumor.10 patients developed postoperative ascites and were managed with diuretics.

Manufacturer Narrative

A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is estimated based on the first year used in the study in the article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN AQM DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18680886
• MDR Text Key: 335074344
• Report Number: 1226420-2024-00005
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK AQM DEV
• Device Catalogue Number: MAE UNK AQM DEV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male